Viewing Study NCT01280227



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Last Modification Date: 2024-10-26 @ 10:30 AM
Study NCT ID: NCT01280227
Status: COMPLETED
Last Update Posted: 2017-04-06
First Post: 2009-09-01

Brief Title: Supporting Patient Provider Communication in Paediatric Care
Sponsor: Oslo University Hospital
Organization: Oslo University Hospital

Study Overview

Official Title: Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SiSom
Brief Summary: Children with Cancer or congenital heart disease CHD experience complex physical psychosocial and behavioural symptoms and problems due to the illness treatment and medical procedures To help children cope with their problems and prevent psychological distress the investigators developed SiSom a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad portable computer

This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses When children use SiSom to report their symptoms and problems and this information is provided to their clinicians in their outpatient consultations

Children and parents will experience less anxiety
Children and parents will be more satisfied with the outpatient visit
There will be greater congruence between childrens reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care

To better understand the mechanisms by which these effects may occur the investigators will also explore

Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour participation initiative and person addressed
The relationships among outcomes of patient-provider communication congruence between patients reported symptoms and those addressed by their clinicians and childrens and parents anxiety and satisfaction and how these relationships differ between treatment and control conditions

Finally the investigators will investigate time requirements ease of use and usefulness of SiSom by children and clinicians

For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions This study will contribute to improving patient-centred care for a particularly vulnerable population and to a better understanding of the triadic communication and interactions among child-parent and clinician
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
175389V50 None None None